Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate
Recruiting
Phase 4
Interventional Study
Cleft Lip and Palate
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 15
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Health Services Research
- Participants needed
- 40 (estimated)
- Sponsor
- The University of Texas Health Science Center, Houston · Other
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About This Trial
The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)/Demineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to see if patients who are treated with DBM/BMP will have reduced post-operative pai…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient with CLP(unilateral or bilateral)
* Radiographically evident open bone defect of the alveolus
* Dentition evaluated by orthodontist and cleared for ABG surgery
Exclusion Criteria:
* Patients without CLP
* Previous failed repair of alveolar cleft
* Patients who have p…
Contacts